cros perspectives on effective relationships with sponsors
TRANSCRIPT
CROs Perspectives on Effective Relationships with
Sponsors
Chris Chase
RTI LLC Brookings SDDept Vet & Biomed Sci
South Dakota State University
Credits Weinberg Group-Pros & Cons of Working with
Contract Research Organizationshttps://weinberggroup.com/blog/pros-cons-working-with-cro/
BioPharm- Establishing a Successful CRO–Client Relationship http://www.biopharminternational.com/establishing-successful-cro-client-relationship
25 Years in CRO business
Background Sisseton
Pre-Vet SDSU
Iowa State DVM 1980
Practiced 5 years in Viborg
Graduate School- University of Wisconsin-Madison-MS & PhD
Relief and consulting practice work 1985-2009
Background ARS Laramie WY 1990-1992 Bluetongue and Arbovirus research
SDSU 1992
Flandreau Veterinary Clinic 1992-2009
Rural Technologies Inc Contract Research Organization Founded 1994
Background Chase Consulting Pfizer/Zoetis Animal Health Merial Animal Health/Boehringer Ingelheim
Vetmedica Schering Plough/Intervet/Merck Novartis/Elanco Animal Health Boehringer Ingelheim Vetmedica Hipra Pharmgate Speak on immunology, virology and vaccinology State and national associations Internationally
Serendipity Serendip, the old Persian name for Sri Lanka
is the effect by which one accidentally discovers something fortunate
Collaborations National Animal Disease
Center Julia Ridpath John Neill
SDSU Arnold Hippen, Johan Osorio-
Dairy Science Jeff Clapper, Zach Smith,
Amanda Weaver-Animal Science Adam Hoppe- Bio/Chem Alan Young-Vet Science
Rural Technologies, Inc.
RTI was founded to develop and market products or services from basic science discoveries through industry, university, and government partnerships. Since its inception in 1994, RTI has funded this effort through grants and contract research.
Co-founded with David Hurley
Contract Research RTI has conducted over 300 contract studies including
bacterial, viral, immunological, and nutritional studies in the last 6 years.
RTI has developed 6 new challenge models within the last three years.
• Contract Research Organization• Basic and Applied Research:
• Focus– Virology– Microbiology– Immunology– Nutrition
• Research Grants• Diagnostic Reagents
Services and Products
• PorcineFarrow to finish, gilts, gnotobiotic, and seronegative sources
• BovineHeifers, cows, cow-calf, seronegative calves, and colostrum-deprived calves
● Poultry SPF chicks, broilers, laying hens
Canine
RTI Core Species
Contract ResearchTypes of Trials
Biologicals – VaccineEfficacy trials – USDASafety- USDABackpassage – USDA
Pharmaceutical – AntimicrobialGeneral health – morbidity/mortalitySafety-FDAPhase 1 – Proof of concept/marketing
NutritionFeed and WeighGI Morphology – MorphometricsImmunological Responses
RTI, LLC Executive Leadership
Rollie NevinsChief Executive and Financial Officer
35 years Experience in the food animal industry
Carol Rinehart, PhDRegulatory Affairs
35 years Clinical Research and Vaccine Licensing
Experience (Licensed 27 products USDA)
Chris Chase, DVM, PhDChief Scientific Officer
30 years Clinical Veterinary Medicine and
Research Experience
Kipp Erickson, PhDChief Operating Officer
25 years Experience in the human and animal health
industry
Why use CRO-Advantages? Sponsors can delegate all their duties and
functions to a CRO
CROs have the necessary resources already in place
CROs are prepared to move forward
Better idea upfront about how much a project may cost
IACUC & Clinical Facilities
Qualified Team
Research Models
GLP & GMP Laboratory
Regulatory & Licensing Services
Discovery and Development
Quality Assurance
Providing a comprehensive approach to research….
GCP & GLP Clinical Trials
Why use CRO-Advantages? Sponsors can delegate all their duties and
functions to a CRO
CROs have the necessary resources already in place
CROs are prepared to move forward
Better idea upfront about how much a project may cost
Clinical Facilities at a Glance 21,000 sq. foot, BSL2 Clinical Building, Brookings,
SD opened in 2016 Climate controlled, Bio-filtered rooms
12,000 sq. foot, BSL2 Clinical Building, Hudson, SD Climate controlled, Bio-filtered rooms
6 additional BSL2 & BSL1 cattle and swine facility near Brookings, SD
Poultry research site, Stilwell, KS
RTI’s New Animal Research Facility
Michelle Blaha, DVMClinical Research Veterinarian and
Principal Investigator8 years Experience animal
health and clinical research
Eduardo Vivas, MS, PhD, DVMVeterinarian, Investigator
Kansas City Facility Manager20+ years Experience animal health
and clinical research
Brittany DiVerde, DVMClinical Research
Veterinarian, Investigator8 years Experience in animal and public health, and clinical
research.
Sara Vander Wal, BSClinical Research Project Manager
IACUC Coordinator 7 years Experience animal health
and clinical research
RTI, LLC Clinical Leadership
Why use CRO-Advantages? Sponsors can delegate all their duties and
functions to a CRO
CROs have the necessary resources already in place
CROs are prepared to move forward
Better idea upfront about how much a project may cost
RTI Expertise
• 2013• 8 Full-time staff• 4 Part-time staff
• 2019• 25 Full-time staff• 8 Part-time staff
Animal Research ModelsBovine
• Bovine Coronavirus Challenge Model
• BHV Type 1 Respiratory Challenge Model
• BHV Type 1 Fetal Protection Model
• Bovine Rotavirus Challenge Model
• BRSV Challenge Model
• BVDV Type I and II Challenge Models
• BVDV Fetal Protection Model
• Leptospirosis Challenge Model
Porcine• E. coli PWD Model (F18, K88)• Erysipelothrix rhusiopathiae• Mycotoxin (ZEA)• Porcine Parvovirus• PRRSV Nursery Model• PRRSV Fetal Persistence Model• Mycoplasma hyopneumoniae Model• Porcine Circovirus 2• Porcine Epidemic diarrhea virus Poultry Salmonella typimurium Salmonella enterditis Coccidia (Eimeria spp) Marek’s Disease VirusGeneral• Field Safety Studies
Customized research models
Why use CRO-Advantages? Sponsors can delegate all their duties and
functions to a CRO
CROs have the necessary resources already in place
CROs are prepared to move forward
Better idea upfront about how much a project may cost
Why use CRO-Advantages? Sponsors can delegate all their duties and
functions to a CRO
CROs have the necessary resources already in place
CROs are prepared to move forward
Better idea upfront about how much a project may cost Extensive budget development that often includes items
that the client may include as overhead in internal studies- wake up call to Client on costs
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO
It can be difficult to maintain oversight
Multiple audits are necessary
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO While delegation can mean that program tasks get completed,
there is no automatic assurance that those tasks will be completed properly.
The Sponsor retains ultimate responsibility for the program regardless of the duties and functions delegated to the CRO.
Any problem with anything related to the CRO’s actions, the Sponsor must deal with the consequences.
It can be difficult to maintain oversight
Multiple audits are necessary
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO
It can be difficult to maintain oversight
Multiple audits are necessary
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO
It can be difficult to maintain oversight Sponsors are not involved with the day-to-day operations
of the CRO. The line of communication is not always clear. The larger and more complex the trial, the more difficult it
is to maintain oversight.
Multiple audits are necessary
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO
It can be difficult to maintain oversight
Multiple audits are necessary
Why use CRO-Disadvantages?
Sponsors can delegate all their duties and functions to a CRO
It can be difficult to maintain oversight
Multiple audits are necessary Sponsor must conduct multiple audits to protect their interests. Conduct a prequalification trial to ensure that the CRO can provide
the services that the Sponsor needs with the necessary quality. Conduct routine audits at points during the trial to ensure the
quality of the program, and conducting an audit near the end of the program to make sure that the program is closed properly.
Audits are less of a con than they are “must-haves.”
Keys to Successful CRO-Client Relationships
Requirement of Project Stated Pitfall- Ambiguous project aims- Type of study-Developmental, pilot, pivotal, marketing Aim of Study-Clear and defined Negative Outcomes- many changes made, time wasted and
project off-track Solutions Agree on roles and scope of project Ensure technical, confidential agreements in place Agree and sign off on technical documents- understand “high
risk” technical studies
Contract ResearchTypes of Trials
Biologicals – VaccineDevelopmentalEfficacy trials – USDASafetyBackpassage – USDA
Pharmaceutical – AntimicrobialFDA label
General health – morbidity/mortalityPhase 1 – Proof of concept/marketing
NutritionFeed and WeighGI Morphology – MorphometricsImmunological Responses
Keys to Successful CRO-Client Relationships
Agreed timelines Pitfall- False expectation of project delivery Is Clients Product ready to test?- potency, import testing,
manufacturing failure Inadequate scheduling at CRO Negative Outcomes- unhappy client
Solutions Feasibility (pilot) study may give more accurate estimate of
outcomes and timelines Provide feedback on any delays or problems as soon as
possible
Keys to Successful CRO-Client Relationships
Regular communication Pitfall- Project progress not monitored Negative Outcomes- client losses confidence in CRO
Solutions Set up regular update times by email, tele- or video-
conferencing
Keys to Successful CRO-Client Relationships
Changes are required Potential Pitfall- Too much time spent on agreeing to
changes Negative Outcomes- changes put the project behind
schedule Solutions CRO flexibility to react quickly to implement changes
including the documentation
Keys to Successful CRO-Client Relationships
Test article availability Potential Pitfall- Cannot perform testing on time Negative Outcome- CRO may need to reschedule trial
Solutions Provide current information to CRO on test article timeline Prepare an alternate timeline if the test article release is
delayed
Keys to Successful CRO-Client Relationships
Review of Documentation Potential Pitfall- Documents awaiting review lead to
project delay Solutions Have dedicated teams ready in place at both sides to ensure
timely review
Keys to Successful CRO-Client Relationships
Delivery of Final Report Potential Pitfall- Delay in Final Report leads to delay for
agency submission Solutions CRO puts together outline for assembling Final Report at the
initiation of the study CRO communicates regularly on progress of Final Report
Keys to Successful CRO-Client Relationships
Financial Considerations Protocol Development and Budgeting Client receives the budget in a timely manner Client needs to be prepared to pay for protocol development
and budgeting to the CRO when the CRO does not do the study
Study Payments Financial Terms and payment schedule need to be clearly
stated and executed Delays in disbursement need to be communicated
Delayed payments affect the goodwill between the CRO and client
CRO SWOT Analysis Strengths Respond rapidly Resources and Expertise available
Weakness Cyclic business and AHI acquisitions Control for Client
Opportunities AHI acquisitions and Startups VFD and alternatives to antimicrobials Define mechanisms not just efficacy
Threats Cyclic business and AHI acquisitions
Summary Best Opportunity for Improvement -Communication Communication between CRO-client on your needs and
expectations and CRO’s expertise Communication between CRO-client budget, protocol,
study Communication between CRO-client during the study Communication between CRO-client- final report,
publications and post-study debrief (the good, the bad and the ugly)